Who benefits from indirect prevention and treatment of depression using an online intervention for insomnia? Results from an individual-participant data meta-analysis.

BACKGROUND: Major depressive disorder (MDD) is highly prevalent and burdensome for individuals and society. While there are psychological interventions able to prevent and treat MDD, uptake remains low. To overcome structural and attitudinal barriers, an indirect approach of using online insomnia interventions seems promising because insomnia is less stigmatized, predicts MDD onset, is often comorbid and can outlast MDD treatment. This individual-participant-data meta-analysis evaluated the potential of the online insomnia intervention GET.ON Recovery as an indirect treatment to reduce depressive symptom severity (DSS) and potential MDD onset across a range of participant characteristics. METHODS: Efficacy on depressive symptom outcomes was evaluated using multilevel regression models controlling for baseline severity. To identify potential effect moderators, clinical, sociodemographic, and work-related variables were investigated using univariable moderation and random-forest methodology before developing a multivariable decision tree. RESULTS: IPD were obtained from four of seven eligible studies (N = 561); concentrating on workers with high work-stress. DSS was significantly lower in the intervention group both at post-assessment (d = -0.71 [95% CI-0.92 to -0.51]) and at follow-up (d = -0.84 [95% CI -1.11 to -0.57]). In the subsample (n = 121) without potential MDD at baseline, there were no significant group differences in onset of potential MDD. Moderation analyses revealed that effects on DSS differed significantly across baseline severity groups with effect sizes between d = -0.48 and -0.87 (post) and d = - 0.66 to -0.99 (follow-up), while no other sociodemographic, clinical, or work-related characteristics were significant moderators. CONCLUSIONS: An online insomnia intervention is a promising approach to effectively reduce DSS in a preventive and treatment setting.

Evaluating a multimodal, clinical and work-directed intervention (RTW-PIA) to support sustainable return to work among employees with mental disorders: study protocol of a multicentre, randomised controlled trial.

BACKGROUND: Mental disorders (MDs) are one of the leading causes for workforce sickness absence and disability worldwide. The burden, costs and challenges are enormous for the individuals concerned, employers and society at large. Although most MDs are characterised by a high risk of relapse after treatment or by chronic courses, interventions that link medical-psychotherapeutic approaches with work-directed components to facilitate a sustainable return to work (RTW) are rare. This protocol describes the design of a study to evaluate the (cost-)effectiveness and implementation process of a multimodal, clinical and work-directed intervention, called RTW-PIA, aimed at employees with MDs to achieve sustainable RTW in Germany. METHODS: The study consists of an effectiveness, a health-economic and a process evaluation, designed as a two-armed, multicentre, randomised controlled trial, conducted in German psychiatric outpatient clinics. Sick-listed employees with MDs will receive either the 18-month RTW-PIA treatment in conjunction with care as usual, or care as usual only. RTW-PIA consists of a face-to-face individual RTW support, RTW aftercare group meetings, and web-based aftercare. Assessments will be conducted at baseline and 6, 12, 18 and 24 months after completion of baseline survey. The primary outcome is the employees´ achievement of sustainable RTW, defined as reporting less than six weeks of working days missed out due to sickness absence within 12 months after first RTW. Secondary outcomes include health-related quality of life, mental functioning, RTW self-efficacy, overall job satisfaction, severity of mental illness and work ability. The health-economic evaluation will be conducted from a societal and public health care perspective, as well as from the employer's perspective in a cost-benefit analysis. The design will be supplemented by a qualitative effect evaluation using pre- and post-interviews, and a multimethod process evaluation examining various predefined key process indicators from different stakeholder perspectives. DISCUSSION: By applying a comprehensive, multimethodological evaluation design, this study captures various facets of RTW-PIA. In case of promising results for sustainable RTW, RTW-PIA may be integrated into standard care within German psychiatric outpatient clinics. TRIAL REGISTRATION: The study was prospectively registered with the German Clinical Trials Register ( DRKS00026232 , 1 September 2021).

Efficacy and Moderators of Internet-Based Interventions in Adults with Subthreshold Depression: An Individual Participant Data Meta-Analysis of Randomized Controlled Trials.

INTRODUCTION: Evidence on effects of Internet-based interventions to treat subthreshold depression (sD) and prevent the onset of major depression (MDD) is inconsistent. OBJECTIVE: We conducted an individual participant data meta-analysis to determine differences between intervention and control groups (IG, CG) in depressive symptom severity (DSS), treatment response, close to symptom-free status, symptom deterioration and MDD onset as well as moderators of intervention outcomes. METHODS: Randomized controlled trials were identified through systematic searches via PubMed, PsycINFO, Embase and Cochrane Library. Multilevel regression analyses were used to examine efficacy and moderators. RESULTS: Seven trials (2,186 participants) were included. The IG was superior in DSS at all measurement points (posttreatment: 6-12 weeks; Hedges' g = 0.39 [95% CI: 0.25-0.53]; follow-up 1: 3-6 months; g = 0.30 [95% CI: 0.15-0.45]; follow-up 2: 12 months, g = 0.27 [95% CI: 0.07-0.47], compared with the CG. Significantly more participants in the IG than in the CG reached response and close to symptom-free status at all measurement points. A significant difference in symptom deterioration between the groups was found at the posttreatment assessment and follow-up 2. Incidence rates for MDD onset within 12 months were lower in the IG (19%) than in the CG (26%). Higher initial DSS and older age were identified as moderators of intervention effect on DSS. CONCLUSIONS: Our findings provide evidence for Internet-based interventions to be a suitable low-threshold intervention to treat individuals with sD and to reduce the incidence of MDD. This might be particularly true for older people with a substantial symptom burden.

A systematic review of trial-based economic evaluations of internet- and mobile-based interventions for substance use disorders.

BACKGROUND: Substance use disorders (SUDs) contribute significantly to global rates of morbidity and mortality. Internet- and mobile-based interventions (IMIs) have been suggested as an adjunct to face-to-face health services. However, the evidence for the cost-effectiveness of IMIs for SUDs is scant. METHODS: A comprehensive literature search in PubMed, PsycINFO, the Cochrane Central Register of Controlled Trials, NHS Economic Evaluations Database, NHS Health Technology Assessment Database, Office of Health Economics Evaluations Database and EconLit was conducted. We included economic evaluations alongside randomized controlled trials of IMIs for SUDs compared with a control group. RESULTS: Of 1687 abstracts identified, 11 studies met the inclusion criteria. Targeted conditions were alcohol use disorder (four studies) and tobacco smoking (five studies) whereas two studies included any SUD. Cost-effectiveness results demonstrated that IMIs had a firm probability of being more cost-effective than TAU (e.g. less costs per additional abstinent person). Compared with (online) psycho-education, evidence towards an additional benefit of IMIs was less clear. Regarding cost-utility (e.g. costs per quality-adjusted life year gained), except for one study, results suggested that TAU and online psycho-education would probably be more preferable than IMIs. Quality of study reporting was at least adequate. CONCLUSIONS: The likelihood of IMIs being more cost-effective than TAU looks promising but more economic evaluations are needed in order to determine the economic merit of IMIs. With an increasing pressure on health care budgets, strategies to disseminate effective interventions at affordable costs are required. This review suggests that IMIs might carry that promise and have potential as a cost-effective strategy to scale-up existing evidence-based treatments for SUDs. SYSTEMATIC REVIEW REGISTRATION: The systematic review has been registered in the PROSPERO database (no. CRD42018099486).

Guided Internet-Based Cognitive Behavioral Therapy for Insomnia: Health-Economic Evaluation From the Societal and Public Health Care Perspective Alongside a Randomized Controlled Trial.

BACKGROUND: The evidence base for internet-based cognitive behavioral therapy for insomnia (iCBT-I) is firm; however, little is known about iCBT-I's health-economic effects. OBJECTIVE: This study aimed to evaluate the cost-effectiveness and cost-utility of iCBT-I in reducing insomnia among schoolteachers. METHODS: Schoolteachers (N=128) with clinically significant insomnia symptoms and work-related rumination were randomized to guided iCBT-I or a wait list control group, both with unrestricted access to treatment as usual. Health care use, patient and family expenditures, and productivity losses were self-assessed and used for costing from a societal and a public health care perspective. Costs were related to symptom-free status (score <8 on the insomnia severity index) and quality-adjusted life years (QALYs) gained. Sampling error was handled using nonparametric bootstrapping. RESULTS: Statistically significant differences favoring the intervention group were found for both health outcomes (symptom-free status yes or no: ß=.30; 95% CI 0.16-0.43; QALYs: ß=.019, 95% CI 0.01-0.03). From a societal perspective, iCBT-I had a 94% probability of dominating the wait list control for both health outcomes. From a public health care perspective, iCBT-I was more effective but also more expensive than the wait list control, resulting in an incremental cost-effectiveness ratio of €650 per symptom-free individual. In terms of QALYs, the incremental cost-effectiveness ratio was €11,285. At a willingness-to-pay threshold of €20,000 per QALY gained, the intervention's probability of being cost-effective was 89%. CONCLUSIONS: Our trial indicates that iCBT could be considered as a good value-for-money intervention for insomnia. TRIAL REGISTRATION: German Clinical Trial Registry: DRKS00004700; https://tinyurl.com/2nnk57jm. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/1745-6215-14-169.

Prediction of major depressive disorder onset in college students.

BACKGROUND: Major depressive disorder (MDD) in college students is associated with substantial burden. AIMS: To assess 1-year incidence of MDD among incoming freshmen and predictors of MDD-incidence in a representative sample of students. METHOD: Prospective cohort study of first-year college students (baseline: n = 2,519, 1-year follow-up: n = 958) RESULTS: The incidence of MDD within the first year of college was 6.9% (SE = 0.8). The most important individual-level predictors of onset were prior suicide plans and/or attempts (OR = 9.5). The strongest population-level baseline predictors were history of childhood-adolescent trauma, stressful experience in the past 12 months, parental psychopathology, and other 12-month mental disorder. Multivariate cross-validated prediction (cross-validated AUC = 0.73) suggest that 36.1% of incident MDD cases in a replication sample would occur among the 10% of students at highest predicted risk (24.5% predicted incidence in this highest-risk subgroup). CONCLUSIONS: Screening at college entrance is a promising strategy to identify students at risk of MDD onset, which may improve the development and deployment of targeted preventive interventions.

Clinical and cost-effectiveness of guided internet-based interventions in the indicated prevention of depression in green professions (PROD-A): study protocol of a 36-month follow-up pragmatic randomized controlled trial.

BACKGROUND: People in green professions are exposed to a variety of risk factors, which could possibly enhance the development of depression. Amongst possible prevention approaches, internet- and mobile-based interventions (IMIs) have been shown to be effective and scalable. However, little is known about the effectiveness in green professions. The aim of the present study is to examine the (cost-)effectiveness of a tailored IMI program for reducing depressive symptoms and preventing the onset of clinical depression compared to enhanced treatment as usual (TAU+). METHODS: A pragmatic randomized controlled trial (RCT) will be conducted to evaluate a tailored and therapeutically guided preventive IMI program in comparison to TAU+ with follow-ups at post-treatment (9 weeks), 6-, 12-, 24-, and 36-months. Entrepreneurs in green professions, collaborating spouses, family members and pensioners (N = 360) with sufficient insurance status and at least subthreshold depression (PHQ-9 ≥ 5) are eligible for inclusion. Primary outcome is depressive symptom severity (QIDS-SR16). Secondary outcomes include incidence of depression (QIDS-SR16), quality of life (AQoL-8D) and negative treatment effects (INEP). A health-economic evaluation will be conducted from a societal perspective. The IMI program is provided by psychologists of an external service company and consists of six guided IMIs (6-8 modules, duration: 6-8 weeks) targeting different symptoms (depressive mood, depressive mood with comorbid diabetes, perceived stress, insomnia, panic and agoraphobic symptoms or harmful alcohol use). Intervention choice depends on a screening of participants' symptoms and individual preferences. The intervention phase is followed by a 12-months consolidating phase with monthly contact to the e-coach. DISCUSSION: This is the first pragmatic RCT investigating long-term effectiveness of a tailored guided IMI program for depression prevention in green professions. The present trial builds on a large-scale strategy for depression prevention in green professions. The intended implementation of the IMI program with a nationwide rollout has the potential to reduce overall depression burden and associated health care costs in case of given effectiveness. TRIAL REGISTRATION: German Clinical Trial Registration: DRKS00014000 . Registered on 09 April 2018.

Web-based intervention for depressive symptoms in adults with types 1 and 2 diabetes mellitus: a health economic evaluation.

BACKGROUND: Web-based interventions are effective in reducing depression. However, the evidence for the cost-effectiveness of these interventions is scarce.AimsThe aim is to assess the cost-effectiveness of a web-based intervention (GET.ON M.E.D.) for individuals with diabetes and comorbid depression compared with an active control group receiving web-based psychoeducation. METHOD: We conducted a cost-effectiveness analysis with treatment response as the outcome and a cost-utility analysis with quality-adjusted life-years (QALYs) alongside a randomised controlled trial with 260 participants. RESULTS: At a willingness-to-pay ceiling of €5000 for a treatment response, the intervention has a 97% probability of being regarded as cost-effective compared with the active control group. If society is willing to pay €14 000 for an additional QALY, the intervention has a 51% probability of being cost-effective. CONCLUSIONS: This web-based intervention for individuals with diabetes and comorbid depression demonstrated a high probability of being cost-effective compared with an active control group.Declaration of interestS.N., D.D.E., D.L., M.B. and B.F. are stakeholders of the Institute for Online Health Trainings, which aims to transfer scientific knowledge related to this research into routine healthcare.

Cost effectiveness of guided Internet-based interventions for depression in comparison with control conditions: An individual-participant data meta-analysis.

BACKGROUND: There is limited evidence on the cost effectiveness of Internet-based treatments for depression. The aim was to evaluate the cost effectiveness of guided Internet-based interventions for depression compared to controls. METHODS: Individual-participant data from five randomized controlled trials (RCT), including 1,426 participants, were combined. Cost-effectiveness analyses were conducted at 8 weeks, 6 months, and 12 months follow-up. RESULTS: The guided Internet-based interventions were more costly than the controls, but not statistically significant (12 months mean difference = €406, 95% CI: - 611 to 1,444). The mean differences in clinical effects were not statistically significant (12 months mean difference = 1.75, 95% CI: - .09 to 3.60 in Center for Epidemiologic Studies Depression Scale [CES-D] score, .06, 95% CI: - .02 to .13 in response rate, and .00, 95% CI: - .03 to .03 in quality-adjusted life-years [QALYs]). Cost-effectiveness acceptability curves indicated that high investments are needed to reach an acceptable probability that the intervention is cost effective compared to control for CES-D and response to treatment (e.g., at 12-month follow-up the probability of being cost effective was .95 at a ceiling ratio of 2,000 €/point of improvement in CES-D score). For QALYs, the intervention's probability of being cost effective compared to control was low at the commonly accepted willingness-to-pay threshold (e.g., at 12-month follow-up the probability was .29 and. 31 at a ceiling ratio of 24,000 and 35,000 €/QALY, respectively). CONCLUSIONS: Based on the present findings, guided Internet-based interventions for depression are not considered cost effective compared to controls. However, only a minority of RCTs investigating the clinical effectiveness of guided Internet-based interventions also assessed cost effectiveness and were included in this individual-participant data meta-analysis.

Turning Good Intentions Into Actions by Using the Health Action Process Approach to Predict Adherence to Internet-Based Depression Prevention: Secondary Analysis of a Randomized Controlled Trial.

BACKGROUND: Many individuals engaging in Internet-based interventions fail to complete these treatments as intended. The processes responsible for treatment adherence in Internet-based interventions are still poorly understood. OBJECTIVE: The aim of this study was to investigate to what extent adherence in an Internet-based intervention can be predicted by motivational and volitional factors outlined in the health action process approach (HAPA). METHODS: This study investigated motivational and volitional factors included in HAPA in a randomized controlled trial to predict treatment adherence of N=101 individuals with subclinical depression in the intervention group of a depression prevention intervention (GET.ON Mood Enhancer). Adherence was operationalized as the number of completed treatment modules. Using longitudinal structural equation modeling, HAPA variables (motivational, maintenance, and recovery self-efficacy, outcome expectancies, intention, and planning) were assessed at baseline and their associations with adherence 7 weeks later. RESULTS: Planning predicted adherence. Better planning was, in turn, associated with higher levels of maintenance self-efficacy, and the latter significantly affected treatment adherence via planning. The other hypothesized direct associations were not significant. In total, the HAPA variables accounted for 14% of variance in treatment adherence. CONCLUSIONS: Planning emerged as the strongest predictor of treatment adherence in highly motivated participants in an Internet-based intervention out of all HAPA variables investigated. Findings are in line with the hypothesis that planning facilitates the translation of good intentions into actions. The findings imply that systematically fostering planning skills and maintenance self-efficacy prior to or during Internet-based interventions would help participants to successfully complete these treatments. TRIAL REGISTRATION: German Clinical Trials Register DRKS00005973; https://www.drks.de/drks_web/navigate.do? navigationId=trial.HTML&TRIAL_ID=DRKS00005973 (Archived by WebCite at http://www.webcitation.org/6uxCy64sy).

Preventing Depression in Adults With Subthreshold Depression: Health-Economic Evaluation Alongside a Pragmatic Randomized Controlled Trial of a Web-Based Intervention.

BACKGROUND: Psychological interventions for the prevention of depression might be a cost-effective way to reduce the burden associated with depressive disorders. OBJECTIVE: To evaluate the cost-effectiveness of a Web-based guided self-help intervention to prevent major depressive disorder (MDD) in people with subthreshold depression (sD). METHODS: A pragmatic randomized controlled trial was conducted with follow-up at 12 months. Participants were recruited from the general population via a large statutory health insurance company and an open access website. Participants were randomized to a Web-based guided self-help intervention (ie, cognitive-behavioral therapy and problem-solving therapy assisted by supervised graduate students or health care professionals) in addition to usual care or to usual care supplemented with Web-based psycho-education (enhanced usual care). Depression-free years (DFYs) were assessed by blinded diagnostic raters using the telephone-administered Structured Clinical Interview for DSM-IV Axis Disorders at 6- and 12-month follow-up, covering the period to the previous assessment. Costs were self-assessed through a questionnaire. Costs measured from a societal and health care perspective were related to DFYs and quality-adjusted life years (QALYs). RESULTS: In total, 406 participants were enrolled in the trial. The mean treatment duration was 5.84 (SD 4.37) weeks. On average, participants completed 4.93 of 6 sessions. Significantly more DFYs were gained in the intervention group (0.82 vs 0.70). Likewise, QALY health gains were in favor of the intervention, but only statistically significant when measured with the more sensitive SF-6D. The incremental per-participant costs were €136 (£116). Taking the health care perspective and assuming a willingness-to-pay of €20,000 (£17,000), the intervention's likelihood of being cost-effective was 99% for gaining a DFY and 64% or 99% for gaining an EQ-5D or a SF-6D QALY. CONCLUSIONS: Our study supports guidelines recommending Web-based treatment for sD and adds that this not only restores health in people with sD, but additionally reduces the risk of developing a MDD. Offering the intervention has an acceptable likelihood of being more cost-effective than enhanced usual care and could therefore reach community members on a wider scale. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00004709; http://www.drks.de/DRKS00004709 (Archived by WebCite at http://www.webcitation.org/6kAZVUxy9).

Effect of a Web-Based Guided Self-help Intervention for Prevention of Major Depression in Adults With Subthreshold Depression: A Randomized Clinical Trial.

IMPORTANCE: Evidence-based treatments for major depressive disorder (MDD) are not very successful in improving functional and health outcomes. Attention has increasingly been focused on the prevention of MDD. OBJECTIVE: To evaluate the effectiveness of a web-based guided self-help intervention for the prevention of MDD. DESIGN, SETTING, AND PARTICIPANTS: Two-group randomized clinical trial conducted between March 1, 2013, and March 4, 2015. Participants were recruited in Germany from the general population via a large statutory health insurance company (ie, insurance funded by joint employer-employee contributions). Participants included 406 self-selected adults with subthreshold depression (Centre for Epidemiologic Studies Depression Scale score ≥16, no current MDD according to Diagnostic and Statistical Manual of Mental Disorders [Fourth Edition, Text Revision] criteria). INTERVENTIONS: All participants had unrestricted access to usual care (visits to the primary care clinician) and were randomized to either a web-based guided self-help intervention (cognitive-behavioral and problem-solving therapy supported by an online trainer; n = 202) or a web-based psychoeducation program (n = 204). MAIN OUTCOMES AND MEASURES: The primary outcome was time to onset of MDD in the intervention group relative to the control group over a 12-month follow-up period as assessed by blinded diagnostic raters using the telephone-administered Structured Clinical Interview for DSM-IV Axis Disorders at 6- and 12-month follow-up, covering the period to the previous assessment. RESULTS: Among 406 randomized patients (mean age, 45 years; 73.9% women), 335 (82%) completed the telephone follow-up at 12 months. Fifty-five participants (27%) in the intervention group experienced MDD compared with 84 participants (41%) in the control group. Cox regression analyses controlling for baseline depressive symptom severity revealed a hazard ratio of 0.59 (95% CI, 0.42-0.82; P = .002) at 12-month follow-up. The number needed to treat to avoid 1 new case of MDD was 5.9 (95% CI, 3.9-14.6). CONCLUSIONS AND RELEVANCE: Among patients with subthreshold depression, the use of a web-based guided self-help intervention compared with enhanced usual care reduced the incidence of MDD over 12 months. Further research is needed to understand whether the effects are generalizable to both first onset of depression and depression recurrence as well as efficacy without the use of an online trainer. TRIAL REGISTRATION: German Clinical Trial Registry Identifier: DRKS00004709.

Effectiveness of a web-based cognitive behavioural intervention for subthreshold depression: pragmatic randomised controlled trial.

BACKGROUND: Research on the effectiveness of treatments for subthreshold depression (sD) is still scarce. The aim of the study was to evaluate the efficacy of a web-based guided self-help intervention (GET.ON Mood Enhancer) in the treatment of sD. METHODS: Participants with sD (n = 406) recruited from the general population via a large health insurance company were randomly allocated to a web-based cognitive behavioural intervention or to enhanced care-as-usual. The primary outcome was the reduction in depressive symptom severity as measured with the Center for Epidemiological Studies Depression Scale at post-treatment and at 6-month follow-up. RESULTS: Participants in the intervention group showed a significantly greater pre-post reduction in depressive symptom severity (d = 1.06; 95% CI: 0.86-1.27) compared to the control condition (d = 0.29; 95% CI: 0.10-0.49). The corresponding between-group effect size was d = 0.69 (95% CI: 0.49-0.89). At 6-month follow-up the effect was reduced to d = 0.28 (95% CI: 0.09-0.48) but was still statistically significant (F1, 403 = 9.240, p = 0.003). CONCLUSIONS: This study lends support to the idea that problem solving coupled with behavioural activation is an effective treatment for sD. In addition, the delivery of this intervention over the Internet might be a promising strategy for the dissemination of psychological interventions for sD on a large scale.

Evaluating the efficacy and cost-effectiveness of web-based indicated prevention of major depression: design of a randomised controlled trial.

BACKGROUND: Major depressive disorder (MDD) imposes a considerable disease burden on individuals and societies. Web-based interventions have shown to be effective in reducing depressive symptom severity. However, it is not known whether web-based interventions may also be effective in preventing the onset of MDD. The aim of this study is to evaluate the (cost-) effectiveness of an indicated web-based guided self-help intervention (GET.ON Mood Enhancer Prevention) on the onset of MDD. METHODS/DESIGN: A randomised controlled trial (RCT) will be conducted to compare the (cost-) effectiveness of the GET.ON Mood Enhancer Prevention training with a control condition exclusively receiving online-based psychoeducation on depression. Adults with subthreshold depression (N = 406) will be recruited from the general population and randomised to one of the two conditions. The primary outcome is time to onset of MDD within a 12-months follow-up period. MDD will be assessed according to DSM-IV criteria as assessed by the telephone-administered Structured Clinical Interview for DSM-IV (SCID). Time to onset of MDD will be assessed using life charts. Secondary outcomes include changes on various indicators of depressive symptom severity, anxiety and quality of life from baseline to post-treatment, to a 6-month and a 12-month follow up. Additionally, an economic evaluation using a societal perspective will be conducted to examine the intervention's cost-effectiveness. DISCUSSION: This is one of the first randomised controlled trials that examines the effect of an indicated guided self-help web-based intervention on the incidence of major depression. If shown to be effective, the intervention will contribute to reducing the disease burden due to MDD in the general population. TRIAL REGISTRATION: German Clinical Trial Registration DRKS00004709.

Acceptance of a Web-Based Intervention in Individuals Who Committed Sexual Offenses Against Children: Cross-Sectional Study.

BACKGROUND: Individuals who have committed sexual offenses against children often have difficulties finding treatment, despite its potential effectiveness. Although the development of web-based interventions could enhance therapeutic supply, up to now the acceptance thereof among this target group is unknown. OBJECTIVE: For the first time, this study assesses the acceptance of a web-based intervention among individuals who committed sexual offenses against children and analyzes variables that predict acceptance. Following the Unified Theory of Acceptance and Use of Technology (UTAUT), it is assumed that acceptance of web-based interventions in individuals who have committed sexual offenses against children follows the same mechanisms as for individuals in general psychiatry. METHODS: This cross-sectional study is based on the data from an ongoing clinical trial (@myTabu) evaluating the effectiveness of a web-based intervention in individuals who committed sexual offenses against children (N=113). Acceptance level was measured using a questionnaire based on the UTAUT and modified for the target group. Furthermore, predictors of acceptance from the UTAUT (performance expectancy, effort expectancy, and social influence [SI]), attitudes toward web-based interventions, and internet anxiety were assessed at baseline. RESULTS: Most participants (61.1%, 69/113), reported high acceptance, while 36.3% (41/113) of them indicated moderate acceptance, and 2.7% (3/113) of them expressed low acceptance. In a linear regression model, the predictors explained 41.2% of the variance (F11,101=9.055; P=.01). Attitudes toward web-based interventions (B=0.398, 95% CI 0.16-0.64; P=.001) and SI (B=0.183, 95% CI 0.03-0.38; P=.04) significantly predicted acceptance. Post hoc explorative analysis showed that the participants' belief that people close to them would recommend the use of a web-based intervention is a predictor of acceptance. In contrast, the belief that their community supervisor would recommend the use thereof was not predictive in this respect. CONCLUSIONS: For the participants of this study, we identified high acceptance of web-based interventions for the majority of participants. SI and the participants' attitudes toward web-based interventions were important in predicting acceptance. TRIAL REGISTRATION: German Clinical Trial Registration (DRKS, Deutsches Register Klinischer Studien) DRKS 00021256; https://drks.de/search/de/trial/DRKS00021256.

Are web-based stress management interventions effective as an indirect treatment for depression? An individual participant data meta-analysis of six randomised trials.

QUESTION: Depression is highly prevalent and associated with numerous adverse consequences for both individuals and society. Due to low uptake of direct treatment, interventions that target related, but less stigmatising problems, such as perceived stress, have emerged as a new research paradigm.This individual participant data (IPD) meta-analysis examines if a web-based stress management intervention can be used as an 'indirect' treatment of depression. STUDY SELECTION AND ANALYSIS: Bayesian one-stage models were used to estimate pooled effects on depressive symptom severity, minimally important improvement and reliable deterioration. The dose-response relationship was examined using multilevel additive models, and IPD network meta-analysis was employed to estimate the effect of guidance. FINDINGS: In total, N=1235 patients suffering from clinical-level depression from K=6 randomised trials were included. Moderate-to-large effects were found on depressive symptom severity at 7 weeks post-intervention (d=-0.65; 95% credibility interval (CrI): -0.84 to -0.48) as measured with the Center for Epidemiological Studies' Depression Scale. Effects were sustained at 3-month follow-up (d=-0.74; 95% CrI: -1.01 to -0.48). Post-intervention symptom severity was linearly related to the number of completed sessions. The incremental impact of guidance was estimated at d=-0.25 (95% CrI: -1.30 to 0.82), with a 35% posterior probability that guided and unguided formats produce equivalent effects. CONCLUSIONS: Our results indicate that web-based stress management can serve as an indirect treatment, yielding effects comparable with direct interventions for depression. Further research is needed to determine if such formats can indeed increase the utilisation of evidence-based treatment, and to corroborate the favourable effects for human guidance. STUDY REGISTRATION: Open material repository: osf.io/dbjc8, osf.io/3qtbe. TRIAL REGISTRATION NUMBER: German Clinical Trial Registration (DRKS): DRKS00004749, DRKS00005112, DRKS00005384, DRKS00005687, DRKS00005699, DRKS00005990.

Evaluation of randomized controlled trials: a primer and tutorial for mental health researchers.

BACKGROUND: Considered one of the highest levels of evidence, results of randomized controlled trials (RCTs) remain an essential building block in mental health research. They are frequently used to confirm that an intervention "works" and to guide treatment decisions. Given their importance in the field, it is concerning that the quality of many RCT evaluations in mental health research remains poor. Common errors range from inadequate missing data handling and inappropriate analyses (e.g., baseline randomization tests or analyses of within-group changes) to unduly interpretations of trial results and insufficient reporting. These deficiencies pose a threat to the robustness of mental health research and its impact on patient care. Many of these issues may be avoided in the future if mental health researchers are provided with a better understanding of what constitutes a high-quality RCT evaluation. METHODS: In this primer article, we give an introduction to core concepts and caveats of clinical trial evaluations in mental health research. We also show how to implement current best practices using open-source statistical software. RESULTS: Drawing on Rubin's potential outcome framework, we describe that RCTs put us in a privileged position to study causality by ensuring that the potential outcomes of the randomized groups become exchangeable. We discuss how missing data can threaten the validity of our results if dropouts systematically differ from non-dropouts, introduce trial estimands as a way to co-align analyses with the goals of the evaluation, and explain how to set up an appropriate analysis model to test the treatment effect at one or several assessment points. A novice-friendly tutorial is provided alongside this primer. It lays out concepts in greater detail and showcases how to implement techniques using the statistical software R, based on a real-world RCT dataset. DISCUSSION: Many problems of RCTs already arise at the design stage, and we examine some avoidable and unavoidable "weak spots" of this design in mental health research. For instance, we discuss how lack of prospective registration can give way to issues like outcome switching and selective reporting, how allegiance biases can inflate effect estimates, review recommendations and challenges in blinding patients in mental health RCTs, and describe problems arising from underpowered trials. Lastly, we discuss why not all randomized trials necessarily have a limited external validity and examine how RCTs relate to ongoing efforts to personalize mental health care.

How to promote usage of telehealth interventions for farmers' mental health? A qualitative study on supporting and hindering aspects for acceptance and satisfaction with a personalized telephone coaching for depression prevention.

Low-threshold and remotely delivered preventive interventions, like telephone coaching, are warranted for farmers who experience multiple risk factors for depression, live in underserved areas, and show low help-seeking behavior. Factors facilitating uptake and actual use of effective remote interventions are important to reduce depression disease burden. This study aimed at identifying factors that potentially can influence acceptance of and satisfaction with a telephone coaching in this occupational group.Semi-structured interviews were based on the 'Unified Theory of Acceptance and Use of Technology', the 'Evaluation', and 'Discrepancy' models for satisfaction. Interviews were conducted with 20 of 66 invited participants of a 6-months telephone coaching during an effectiveness or implementation study. Audio-recorded interviews were transcribed and analyzed (deductive-inductive qualitative content analysis). Independent coding by two persons resulted in good agreement (Κ = 0.80). Participants validated results via questionnaire.Overall, 32 supporting (SF) and 14 hindering factors (HF) for acceptance and satisfaction were identified and organized into five dimensions: Coaching result (SF = 9, HF = 3), coach (SF = 9, HF = 1), organization (SF = 5, HF = 2), the telephone as communication medium (SF = 4, HF = 5) and participant characteristics (SF = 5, HF = 3). Most named SFs were 'Flexible appointment arrangement' (n = 19/95 %) and 'low effort' (n = 17/85 %), while most reported HFs were 'lack of visual cues' (n = 12/60 %) and 'social/professional involvement restricts change process' (n = 10/50 %).The perceived changes initiated by coaching, a low effort through telephone conduct, and the indicated personalization were identified as important influencing factors on acceptance and satisfaction based on interviewees' statements. Both may be further enhanced by offering choice and advice for delivery formats (e.g., video-calls) and training of coaches in farm-related issues. Study registration: German Clinical Trial Registrations: DRKS00017078 and DRKS00015655.

Systematic review of economic evaluations for internet- and mobile-based interventions for mental health problems.

In view of the staggering disease and economic burden of mental disorders, internet and mobile-based interventions (IMIs) targeting mental disorders have often been touted to be cost-effective; however, available evidence is inconclusive and outdated. This review aimed to provide an overview of the cost-effectiveness of IMIs for mental disorders and symptoms. A systematic search was conducted for trial-based economic evaluations published before 10th May 2021. Electronic databases (including MEDLINE, PsycINFO, CENTRAL, PSYNDEX, and NHS Economic Evaluations Database) were searched for randomized controlled trials examining IMIs targeting mental disorders and symptoms and conducting a full health economic evaluation. Methodological quality and risk of bias were assessed. Cost-effectiveness was assumed at or below £30,000 per quality-adjusted life year gained. Of the 4044 studies, 36 economic evaluations were reviewed. Guided IMIs were likely to be cost-effective in depression and anxiety. The quality of most evaluations was good, albeit with some risks of bias. Heterogeneity across studies was high because of factors such as different costing methods, design, comparison groups, and outcomes used. IMIs for anxiety and depression have potential to be cost-effective. However, more research is needed into unguided (preventive) IMIs with active control conditions (e.g., treatment as usual) and longer time horizon across a wider range of disorders.Trial registration: PROSPERO Registration No. CRD42018093808.

Telephone coaching for the prevention of depression in farmers: Results from a pragmatic randomized controlled trial.

INTRODUCTION: Farmers have a high risk for depression (MDD). Preventive measures targeting this often remotely living population might reduce depression burden. The study aimed to evaluate the effectiveness of personalized telephone coaching in reducing depressive symptom severity and preventing MDD in farmers compared to enhanced treatment as usual (TAU + ). METHODS: In a two-armed, pragmatic randomized controlled trial (N = 314) with post-treatment at 6 months, farming entrepreneurs, collaborating family members and pensioners with elevated depressive symptoms (PHQ-9 ≥ 5) were randomized to personalized telephone coaching or TAU + . The coaching was provided by psychologists and consists on average of 13 (±7) sessions a 48 min (±15) over 6 months. The primary outcome was depressive symptom severity (QIDS-SR16). RESULTS: Coaching participants showed a significantly greater reduction in depressive symptom severity compared to TAU + (d = 0.39). Whereas reliable symptom deterioration was significantly lower in the intervention group compared to TAU + , no significant group differences were found for reliable improvement and in depression onset. Further significant effects in favor of the intervention group were found for stress (d = 0.34), anxiety (d = 0.30), somatic symptoms (d = 0.39), burnout risk (d = 0.24-0.40) and quality of life (d = 0.28). DISCUSSION: Limiting, we did not apply an upper cutoff score for depressive symptom severity or controlled for previous MDD episodes, leaving open whether the coaching was recurrence/relapse prevention or early treatment. Nevertheless, personalized telephone coaching can effectively improve mental health in farmers. It could play an important role in intervening at an early stage of mental health problems and reducing disease burden related to MDD. TRIAL REGISTRATION NUMBER AND TRIAL REGISTER: German Clinical Trial Registration: DRKS00015655.